budesonide · Calliditas · NDA 215935
Tarpeyo
Earliest generic entry, as listed
23 Jan 2043
Blocked by patent: US 11896719, US 12171882, US 12171883, US 12311057.
Listed patents · 5 unexpired
9 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11896719 | use U-3810 · sets the listed date | 23 Jan 2043 |
| US 12171882 | use U-4085, U-4086 | 23 Jan 2043 |
| US 12171882 listing row | use U-4085 · sets the listed date | 23 Jan 2043 |
| US 12171882 listing row | use U-4086 · sets the listed date | 23 Jan 2043 |
| US 12171883 | drug product · sets the listed date | 23 Jan 2043 |
| US 12311057 | drug product, use U-4085, U-4086, U-4204 | 23 Jan 2043 |
| US 12311057 listing row | drug product, use U-4085 · sets the listed date | 23 Jan 2043 |
| US 12311057 listing row | drug product, use U-4086 · sets the listed date | 23 Jan 2043 |
| US 12311057 listing row | drug product, use U-4204 · sets the listed date | 23 Jan 2043 |
| US 8491932 | drug product, use U-3269, U-3781 | 7 May 2029 |
| US 8491932 listing row | drug product, use U-3269 | 7 May 2029 |
| US 8491932 listing row | drug product, use U-3781 | 7 May 2029 |
Exclusivities · 2 unexpired
| ODE-464 | orphan drug (7 years) | 20 Dec 2030 |
| ODE-389 | orphan drug (7 years) | 15 Dec 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215935 · 001 · RLD | capsule, delayed release, oral | 4MG | 23 Jan 2043 |